A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Number of Participants Who Discontinued Because of an Adverse Event
研究概览
简要总结
This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly subjects with psychosis
排除标准
- •Have an uncontrolled, unstable clinically significant
- •medical condition.
- •Have an established diagnosis of dementia
研究组 & 干预措施
Asenapine 2-10 mg BID
Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
干预措施: Asenapine (Drug)
Asenapine 5-10mg BID
Dose titration from 5 mg to 10 mg BID
干预措施: Asenapine (Drug)
结局指标
主要结局
Number of Participants Who Discontinued Because of an Adverse Event
时间窗: up to 30 days after study medication stop date
Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
时间窗: Day 4 or 8
Cmin defined as pre-dose concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
时间窗: Day 4 or 8
Tmax defined as time to peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
时间窗: Day 4 or 8
Cmax defined as peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
时间窗: Day 4 or 8
AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
Number of Participants Who Experienced an Adverse Event
时间窗: Up to Day 42 (treatment period)
Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
时间窗: Day 4 or 8
dn-Cmax is defined as dose normalized peak concentration.
Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
时间窗: Day 4 or 8
dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.
次要结局
未报告次要终点